Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of COPD (chronic bronchitis, and emphysema) with stable symptoms:
Screening FEV1.0 ≤70% of predicted normal vale and screening FEV1.0/FVC ≤70% (the baseline FEV1.0 should also be ≤70% of predicted normal value on the initial day of administration)
Smoking history ≥ 10 pack-years (a peak-year is 20 cigarettes per day for one year or equivalent)
Male or female patients 40 years of age or older
You may not be if
History of bronchial asthma
History of an atopic disease such as allergic rhinitis
Total blood eosinophil count ≥ 600/µL
Patient treated with antiallergic drugs or anti-histamine drugs
Patients using oral corticosteroid medication at unstable doses (i.e. less than one month on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisolone per day
Patients using inhaled steroid, oral β2 stimulant, theophylline preparation, expectorant or macrolide antibiotic at unstable doses (i.e. less than one month on a stable dose)
Patients using an ACE inhibitor at unstable doses (i.e. less than one month on a stable dose)
Patients with known narrow-angle glaucoma
Patients with known symptomatic prostatic hypertrophy
Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system
Patients with clinically significant abnormal baseline laboratory test values (hematology, blood chemistry, urinalysis). Patients with serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) twice the upper limit of the normal range, bilirubin 150% or creatinine 125% of the upper limit of the normal range were excluded
Patients with a recent history (i.e. within the 3 months prior to the screening visit) of myocardial infarction or heart failure
Patients with any cardiac arrhythmia requiring drug therapy
Patients who were treated with Patients who were treated with β-blockers-blockers
Patients with regular use of daytime oxygen therapy
Patients with known active tuberculosis or with obvious sequela of tuberculosis
Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma were allowed
Patients with a history of cystic fibrosis or bronchiectasis
Patients with upper respiratory tract infection in the past one month prior to the screening visit or during the baseline period
Patients who had taken an investigational drug within one month or six half lives (whichever is greater) prior to the screening visit
Pregnant or nursing women or women of childbearing potential
Clareo Health | Efficacy and Safety of Ba679BR Powder Inhalation in Patients With Chronic Obstructive Pulmonary Disease (COPD)
